FDA approves new dosage of MedPointe's Soma

SOMERSET, N.J. MedPointe Pharmaceuticals has received approval from the Food and Drug Administration for Soma 250 mg as a new dosage of Soma for the relief of discomfort associated with acute, painful musculoskeletal conditions, such as backaches.

Compared to the 350 mg version of Soma, the tolerability of the 250 mg is said to be more favorable and causes less drowsiness. "The clinical benefits of Soma 250 mg are in line with current treatment strategies for back pain which focus on helping patients to return to normal physical activity as quickly as possible," said Lee Ralph, assistant clinical professor in the Department of Family and Preventative Medicine at the University of California, San Diego and a lead author and investigator for the Soma 250 mg clinical trials.

Back pain has led to health care costs of more than $20 billon each year and as much as $50 billion in indirect costs. The new recommended dosage of the 250 mg version of Soma is three times a day and at bedtime.